Background

Initiating a progestin-based contraceptive before the drop in progesterone required to start lactogenesis stage II could theoretically affect lactation. Previous studies have shown that initiating progestin-based contraception in the postnatal period before birth-hospitalization discharge has no detrimental effects on breastfeeding initiation or continuation compared with outpatient interval initiation. However, there are currently no breastfeeding data on the impact of initiating the etonogestrel contraceptive implant in the early postnatal period immediately in the delivery room.

Objective

This study examined the effect of delivery room vs delayed birth-hospitalization contraceptive etonogestrel implant insertion on breastfeeding outcomes.

Study Design

This was a noninferiority randomized controlled trial to determine if time to lactogenesis stage II (initiation of copious milk secretion) differs by timing of etonogestrel implant insertion during the birth-hospitalization. We randomly assigned pregnant people to insertion at 0 to 2 hours (delivery room) vs 24 to 48 hours (delayed) postdelivery. Participants intended to breastfeed, desired a contraceptive implant for postpartum contraception, were fluent in English or Spanish, and had no allergy or contraindication to the etonogestrel implant. We collected demographic information and breastfeeding intentions at enrollment. Onset of lactogenesis stage II was assessed daily using a validated tool. The noninferiority margin for the mean difference in time to lactogenesis stage II was defined as 12 hours in a per-protocol analysis. Additional electronic surveys collected data on breastfeeding and contraceptive continuation at 2 and 4 weeks, and 3, 6, and 12 months.

Results

We enrolled and randomized 95 participants; 77 participants were included in the modified intention-to-treat analysis (n=38 in the delivery room group and n=39 in the delayed group) after excluding 18 because of withdrawing consent, changing contraceptive or breastfeeding plans, or failing to provide primary outcome data. A total of 69 participants were included in the as-treated analysis (n=35 delivery room, n=34 delayed); 8 participants who received the etonogestrel implant outside the protocol windows were excluded, and 2 participants from the delivery room group received the etonogestrel implant at 24 to 48 hours and were analyzed with the delayed group. Participants were similar between groups in age, gestational age, and previous breastfeeding experience. Delivery room insertion was noninferior to delayed birth-hospitalization insertion in time to lactogenesis stage II (delivery room [mean±standard deviation], 65±25 hours; delayed, 73±61 hours; mean difference, −9 hours; 95% confidence interval, −27 to 10). Onset of lactogenesis stage II by postpartum day 3 was not significantly different between the groups. Lactation failure occurred in 5.5% (n=2) participants in the delayed group. Ongoing breastfeeding rates did not differ between the groups, with decreasing rates of any/exclusive breastfeeding over the first postpartum year. Most people continued to use the implant at 12 months, which did not differ by group.

Conclusion

Delivery room insertion of the contraceptive etonogestrel implant does not delay the onset of lactogenesis when compared with initiation later in the birth-hospitalization and therefore should be offered routinely as part of person-centered postpartum contraceptive counseling, regardless of breastfeeding intentions.

中文翻译：

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依托孕烯避孕植入物立即与延迟分娩住院后的泌乳和母乳喂养：一项非劣效性试验

背景

在开始泌乳第二阶段所需的黄体酮下降之前开始使用基于孕激素的避孕药理论上可能会影响泌乳。先前的研究表明，与门诊间隔开始相比，在产后出院前开始基于孕激素的避孕对母乳喂养的开始或继续没有不利影响。然而，目前还没有母乳喂养数据说明在产后早期立即在产房开始植入依托孕烯避孕药的影响。

客观的

本研究检查了产房与延迟分娩住院避孕依托孕烯植入物植入对母乳喂养结果的影响。

学习规划

这是一项非劣效性随机对照试验，旨在确定第二阶段泌乳（大量乳汁分泌开始）的时间是否因依托孕烯植入物植入的出生住院期间的时间而不同。我们随机分配孕妇在分娩后 0 到 2 小时（产房）和 24 到 48 小时（延迟）插入。参与者打算进行母乳喂养，需要用于产后避孕的避孕植入物，英语或西班牙语流利，并且对依托孕烯植入物没有过敏或禁忌症。我们在注册时收集了人口统计信息和母乳喂养意向。每天使用经过验证的工具评估第二阶段泌乳的开始。在符合方案分析中，II 期泌乳时间的平均差异的非劣效性界值被定义为 12 小时。

结果

我们招募并随机分配了 95 名参与者；77 名参与者被纳入改良意向性治疗分析（产房组 n=38，延迟组 n=39），其中 18 名参与者因撤回同意、改变避孕或母乳喂养计划或未能提供主要服务而被排除在外结果数据。共有 69 名参与者被纳入治疗分析（n=35 产房，n=34 延迟）；8 名在方案窗口外接受依托孕烯植入的参与者被排除，2 名来自产房组的参与者在 24 至 48 小时接受依托孕烯植入，并与延迟组一起进行分析。各组参与者的年龄、孕龄和既往母乳喂养经历相似。产房入院时间不劣于延迟产-住院入院至泌乳 II 期（产房 [平均值±标准差]，65±25 小时；延迟，73±61 小时；平均差，-9 小时；95% 置信区间, -27 至 10). 产后第 3 天开始的泌乳第二阶段在各组之间没有显着差异。延迟组中有 5.5% (n=2) 的参与者出现泌乳失败。持续母乳喂养率在各组之间没有差异，在产后第一年任何/纯母乳喂养率都在下降。大多数人在 12 个月时继续使用植入物，这在各组之间没有差异。产后第 3 天开始的泌乳第二阶段在各组之间没有显着差异。延迟组中有 5.5% (n=2) 的参与者出现泌乳失败。持续母乳喂养率在各组之间没有差异，在产后第一年任何/纯母乳喂养率都在下降。大多数人在 12 个月时继续使用植入物，这在各组之间没有差异。产后第 3 天开始的泌乳第二阶段在各组之间没有显着差异。延迟组中有 5.5% (n=2) 的参与者出现泌乳失败。持续母乳喂养率在各组之间没有差异，在产后第一年任何/纯母乳喂养率都在下降。大多数人在 12 个月时继续使用植入物，这在各组之间没有差异。

结论

与在出生住院后期开始相比，在产房植入避孕药依托孕烯植入物不会延迟泌乳的开始，因此无论母乳喂养意图如何，都应作为以人为本的产后避孕咨询的一部分常规提供。